IVYGene Testing

Confirming Cancer Presence

Every day thousands of people in the USA are beginning to fight cancer. In 2016, more
than 4,600 individuals in the U.S. were diagnosed with cancer daily. The first step to
fighting cancer is identifying its presence early, which can be a difficult and
frustrating process. The IvyGene® test is a blood test that uses advanced DNA sequencing methods to
detect the DNA methylation pattern of circulating tumor DNA (ctDNA) in blood
samples in order to both confirm the presence of cancer and give measurable
information about cancer. The IvyGene® test is a non-invasive, accurate tool to aid
physicians in confirming cancer presence at the time of testing. According to studies performed by the National Cancer Institute and the American
Cancer Society, individuals who identified 25 different types of cancer earlier had a
greater chance of survival. In combination with diagnostic tests, the IvyGene® test is
another step towards winning the battle with cancer.

How Does the IvyGene® Test Work?

The test measures the methylation status of cell-free DNA extracted from blood
samples at target gene sites. These target sites have been demonstrated to be
hypermethylated when certain cancers are present. Test results are reported as a
quantitative IvyGene® Score, which indicates the methylation status of the target
sites. The IvyGene® Score is calculated as a composite average of cell-free DNA that is
methylated at the target sites as a fraction of the total cell-free DNA present.

Uses of IvyGene®

IvyGene® is intended to be used in conjunction with other diagnostic and confirmatory
tests, such as Abnormal Imaging, Elevated Genetic Markers, Positive BRCA 1&2 and

How is the IvyGene® test different from other DNA tests?

DNA tests identify the “propensity to have” or the “likelihood” that cancer will occur.
The IvyGene® test identifies actual disease presence at the time of testing.

Why IvyGene®?

NON-Invasive, Quantification, Malignant Cancer Presence, and 5-Day Results

Visit Our Office Today to Receive a Test Kit

The IvyGene® test meets all FDA guidelines as a Laboratory Developed Test and is CLIA registered and CAP accredited. The
IvyGene® test is a confirmatory test that is intended to be used by the ordering physician in conjunction with the patient’s
complete medical history and the results of the standard of care testing. The IvyGene® test has been validated for (4) cancer types
including: breast, colon, liver, and lung. The presence of other cancers may result in an elevated IvyGene® Score. The usefulness
of the IvyGene® test to stage disease or indicate disease prognosis has not been determined. Cancer screening is not an approved utility of the IvyGene® test.

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